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FDA’s New Device Reclassification Process: How New Criteria May Impact Your Device
Just a few weeks ago, the FDA issued proposed regulations that allow it to reclassify a device by administrative order rather than by regulation.
It's a significant change that the agency hopes will bring clarity to the classification and reclassification process.
Order this webinar CD and transcript to find out.
By modifying the Class III device definition, the FDA is trying to be clearer about which devices now classified as Class III cannot be "down-classified." And which ones can.
But there's more. "New information" could result in a device being "up-classified." But some "automatically classified" devices might be down-classified.
Oh yes, "pre-amendment" devices WILL be affected by the new proposed regulations.
To help you get a handle on the changes, FDAnews has engaged three experts from Morgan Lewis FDA Practice.
In an intensive 90-minute session, they take you by the hand and walk you step-by-step through the complexities of the proposed regulations.
To do this, they present two distinct, detailed flow charts that make comparing the old and the new classification and reclassification processes significantly easier:
Flowchart #1 reviews the current reclassification process, in use prior to the issuance of the proposed regulatory changes.
Flowchart #2 outlines the new proposed reclassification process, as initiated by the FDA (or by a petitioner).
Clearly, this in-depth webinar CD and transcript is a must for device manufacturers.
Meet Your Presenters
Beth Bierman has more than 25 years of representing domestic and international companies regarding FDA policies with Morgan Lewis FDA Practice where she is a partner. She has worked on cases including the development, manufacturing, and marketing of medical devices, health information technology, pharmaceuticals, tissue products, combination products, medical foods, and infant formulas. She has instructed medical device companies on how FDA regulations will impact their business and production future.
Phoebe Mounts is a partner in Morgan Lewis FDA Practice with more than 16 years of professional experience regarding public health. She previously worked at John Hopkins University School of Public Health where she published more than 45 articles regarding molecular biology and infectious diseases. She assists clients who are dealing with preclinical studies, emerging technologies and technical manufacturing information.
Michele Buenafe is an associate in Morgan Lewis FDA Practice where she focuses on state and federal regulatory regulations, compliance, and enforcement issues related to medical devices, health IT, pharmaceuticals, controlled substances and human tissue products.
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